Actively Recruiting
Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma
Led by Washington University School of Medicine · Updated on 2026-03-23
20
Participants Needed
1
Research Sites
262 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
K
Karyopharm Therapeutics Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
The outcomes in patients with relapsed multiple myeloma refractory to triple-therapy (anti-CD38, immunomodulatory drugs (IMiD) and proteasome inhibitors (PI)) remain poor. These patients are eligible for chimeric antigen receptor T-cells (CAR-T), which rely on redirecting autologous T-cells to clear myeloma cells by targeting B-cell maturation antigen (BCMA). BCMA CAR-T therapy is not curative, and unlike autologous stem cell transplant, there is currently no standard for maintenance therapy post CAR-T which could potentially increase MRD rates and extend progression-free survival. Selinexor is an exportin (XPO1) inhibitor with direct anti-tumor effect used often as an adjunct with other agents as bridging therapy prior to CAR-T. As selinexor does not affect T-cell yields or fitness, T-cell collection on selinexor for CAR-T manufacturing is safe. The aim of this study is to evaluate the safety and toxicity of selinexor in triple-exposed or refractory multiple myeloma patients with high-risk features (adverse risk cytogenetics, less than complete response (CR) post CAR-T, or extramedullary disease) following BCMA CAR-T therapy. The investigators hypothesize that selinexor as maintenance therapy following CAR-T has the potential to act synergistically with CAR-T cells leading to more durable responses.
CONDITIONS
Official Title
Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of triple-class exposed or refractory multiple myeloma confirmed by pathology
- Received standard of care BCMA CAR-T therapy (cilta-cel; Carvykti)
- Have high-risk cytogenetics or extramedullary disease prior to CAR-T, or less than complete response or MRD-positive disease at 30 days post CAR-T
- Able to monitor disease response using ClonoSEQ MRD testing
- At least 18 years old
- ECOG performance status of 0, 1, or 2
- Adequate bone marrow and organ function around 30 days after CAR-T therapy, including specific blood counts and liver/kidney function
- Agree to use effective contraception during the study and for 90 days after treatment if of childbearing potential
- Able and willing to provide informed consent
You will not qualify if you...
- Active central nervous system involvement of multiple myeloma
- Confirmed disease progression after CAR-T therapy
- Unresolved cytokine release syndrome or neurological toxicity from CAR-T
- Any unresolved severe treatment-related toxicity from CAR-T therapy
- Receiving or planning to receive other anti-myeloma treatments from 28 days post CAR-T through study discontinuation, except certain corticosteroids
- Prior treatment with selinexor or other XPO1 inhibitors after CAR-T
- Serious medical or psychiatric conditions that could interfere with treatment
- Previous organ transplant requiring immunosuppressive therapy
- Prior or current malignancy interfering with study assessments
- Currently receiving other investigational agents
- History of allergic reactions to selinexor or similar compounds
- Active gastrointestinal problems affecting swallowing or absorption
- Uncontrolled infections or significant unstable heart conditions
- Major surgery within 28 days before CAR-T therapy
- Pregnant or breastfeeding; women must have a negative pregnancy test before study entry
- HIV infection without effective treatment or undetectable viral load for 6 months
- Detectable chronic hepatitis B virus infection not controlled by treatment
- Active or untreated hepatitis C infection
AI-Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
M
Mark A Schroeder, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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